Challenges

Biomedicines, among which vaccines and monoclonal antibodies are the most widespread, offer very promising prospects for addressing globally the current needs in healthcare. It is acknowledged in the Pharmaceutical industry that the complexity of upstream cell culture and downstream processes makes it a challenge to maintain a profitable industrial activity based on these products.

Responding to unsatisfied needs

Better understanding cell culture processes

Improving quality control of the final product by implementing Quality by Design (QbD)

Enhancing batch yield and product quality by implementing a nutrient control loop strategy

Prevent batch failure with a frequent monitoring and a reduced sampling

Speeding up process development, scale-up and transfer to production

Fulfilling regulatory requests regarding PAT implementation

Quality by Design (QbD), including Process Analytical Technology (PAT) tools are expected to highly contribute to face these challenges by designing, analyzing and controlling pharmaceutical manufacturing processes, in particular for vaccines and biologics. This is achieved through the robust measurement of Critical Process Parameters (CPP) which are used to ensure that the resulting product will comply with the required Critical Quality Attributes (CQA). MultiVariate Data Analysis (MVDA) is the cornerstone of information processing in these systems, with mathematical tools such as Principal Components Analysis (PCA) and Partial Least-Squares (PLS). The right choice of sensing technology, methodology of measurement, and mathematical tools is essential to implement an efficient and reliable Process Analytical Technology solution. This is particularly true for material such as mammalian cell culture used for biodrug manufacturing, because variability can be significant with living organisms.

Raman spectroscopy has been recently demonstrated as a very efficient Process Analytical Technology instrumental technics for upstream development and bioprocess monitoring, in particular for predicting concentration of conventional metabolites in the cell culture (monitoring of lactate, etc.) and then for monitoring the feeding of nutrients (monitoring of glucose, medium feeding, etc.). However dissemination of this solution needs a Process Analytical Technology sensor, understood as integrated, robust and easy-to-use system.

The challenge of implementing in-line and real-time Raman monitoring of bioprocess also deals with the combination of instrumental, data processing and bioprocess skills.

Solution

RESOLUTION Spectra Systems offers ProCellics™, an integrated GMP in-line and real-time Bioprocess Raman analyzer, dedicated to and optimized for the upstream in-line quantitation of glucose, lactate, glutamate, ammonium, other amino acids and Viable Cell Density (VCD) inside a cell culture bioreactor and for the monitoring of various downstream steps.

ProCellics™ GMP Raman analyzer and probe designed for bioprocess monitoring

ProCellics™ Software dedicated to the building of chemometrics models and real-time monitoring

Services and support to ease implementation and maintenance

ProCellics™ solution is designed to be used by process development teams with no specific skills in Raman spectroscopy or chemometrics.

Benefits

With ProCellics™ bioprocess Raman analyzer, we offer a user-friendly and easily deployed Process Analytical Technology solution specifically targeted to cell culture monitoring as well as monitoring of downstream processes– relieving the user from conducting a costly and time-consuming project of implementation.